Sr. Data Manager
Senior Data Manager - Clinical Research Management Office (CRMO)
The Clinical Research Management Office (CRMO) provides administrative, nursing, and data management support for cancer treatment clinical trials conduced by Lombardi Investigators. This includes all regulatory documents, IRB submissions, budget and contract negotiations, consenting of subjects, case management of patients while on study, side effect management, completion of case report forms, meeting with monitors, maintaining trial information on Lombardi website, design of electronic case report forms for institutional trials.
The Senior Data Manager has the responsibility of managing the data of complex clinical trials portfolios and ensures that data collection is accurate and on time. Duties include but are not limited to:
- Coordinates and organizes the data entry, data locks, monitoring and audit deadlines in their disease group team for complex clinical trial portfolios.
- Manages query resolution in a timely manner and appropriate communication with study team and sponsor.
- Oversees prioritization of studies of high importance (e.g. high accrual, Phase I, data locks, audits, etc.) for data disease group team.
- Assists data disease team to prepare for and participate in internal and external audits.
- Trains and mentors data disease team in prioritizing deadlines. Communicates study status, timeline updates and data deadlines to supervisor.
- Trains and mentors data disease group team on good clinical and research practices, process and regulations in compliance with standard operating procedures.
- Accountable for managing diverse assignments and mentoring other staff as needed for fast accruing studies.
- Works with supervisor in maintaining SOPs, staying up to date with current GCP regulations and continuous process improvement initiatives.
- Collaborates with QA manager and DM supervisor to identify areas of education and quality improvement.
- Bachelor‘s degree; Master's Degree in a Science related field preferred
- 5+ years of clinical research experience
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